NCT03992183终止不适用
TH-146: Cancer Associated Macrophage-Like (CAML) Cells to Enhance Detection of Early Stage Lung Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Determination of prevalence pf CAMLs in Pulmonary modules
研究概览
简要总结
Primary Objective Determine the prevalence of CAMLS in patients with pulmonary nodules.
Secondary Objectives Determine the positive and negative predictive value of CAMLS in patients with pulmonary nodules who undergo biopsy.
Model combinations of clinical factors with the presence/absence of CAMLS to refine strategies for assessment of patients with pulmonary nodules. Evaluate whether these measures result in enhanced T-cell activity and/or NK cell function and number
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referral for a pulmonary nodule that has not yet been biopsied and that meets the definition of an "indeterminate" nodules (i.e. 0.8-3.0 cm).
- •No prior diagnosis of lung cancer or other invasive malignancy within the past 5 years.
- •No history of rheumatologic disease.
- •Age > 18 years.
- •Ability to understand and willingness to sign a written informed consent and HIPAA consent document
排除标准
- •Patients with active, known or suspected autoimmune disease.
- •Prior diagnosis of lung cancer or other invasive malignancy within the past 5 years.
- •Uncontrolled intercurrent illness that would increase the risk of toxicity or limit compliance with study requirements. This includes but is not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Known HIV-positive patients on combination antiretroviral therapy are ineligible because of the abnormal immune response that results from HIV disease (testing is not required).
- •Patients should be excluded if they are known to be positive for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection (testing is not required).
- •Subjects with any history of interstitial lung disease or a history of > or = to grade 2 radiation pneumonitis.
结局指标
主要结局
Determination of prevalence pf CAMLs in Pulmonary modules
时间窗: During the first 2 years of study
Laboratory studies performed on blood drawn at Creatv Microtech will determine the prevalence of CAMLS in pulmonary nodules.
次要结局
- Determination of positive and negative predictive value, sensitivity and specificity of CAMLS in patients with pulmonary nodules who undergo biopsy(Through study completion, an average of 3 years)
- Model combinations of clinical factors with the presence/absence of CAMLs to refine strategies for assessment of patients with pulmonary nodules. Evaluate whether measures result in enhanced T-cell activity/Natural Killer (NK) cell function and number(Through study completion, a maximum of 3 years)
研究者
研究点 (2)
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